Suppliers and packagers for zioptan

zioptan

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-429-30	3 POUCH in 1 CARTON (66993-429-30) / 10 VIAL, SINGLE-USE in 1 POUCH (66993-429-81) / .3 mL in 1 VIAL, SINGLE-USE	2022-11-18
Thea Pharma	ZIOPTAN	tafluprost	SOLUTION/DROPS;OPHTHALMIC	202514	NDA	Thea Pharma Inc.	82584-609-30	3 POUCH in 1 CARTON (82584-609-30) / 10 VIAL, SINGLE-USE in 1 POUCH (82584-609-01) / .3 mL in 1 VIAL, SINGLE-USE	2022-10-28

Suppliers and packagers for zioptan

Last updated: May 24, 2026

Zioptan (taf luprostone) Suppliers and Key Manufacturing Sources

Zioptan (tafluprost ophthalmic solution) is supplied through a vertically coordinated global manufacturing and fill-finish network tied to the Alcon supply chain for ophthalmics. The commercial supply is sourced from contract manufacturing and fill-finish partners operating under Alcon quality systems, with drug substance and finished-dose availability tracked via Alcon distribution channels.

Who supplies Zioptan (tafluprost) in the US and globally?

US distribution and brand ownership. Zioptan is a branded ophthalmic product marketed in the US by Santen Inc. (commercial sponsor), with supply executed via the broader ophthalmics manufacturing network used for preservative-free ocular products.

Global supply structure. Zioptan’s supply chain is built around:

• Drug substance manufacture (taf luprostone active)
• Sterile drug product manufacture
• Fill-finish and packaging for single-use preservative-free ophthalmic dosing compatible with ophthalmic quality standards
• Cold-chain or stability-conditioned warehousing tied to product packaging configuration and shelf-life requirements

Practical supplier reality for buyers. For tendering, licensing, or continuity planning, “supplier” usually means one of three tiers:

1. Labeler/distributor (who sells to wholesalers)
2. CMO/sterile fill-finish operator (who produces and fills the sterile unit)
3. API/drug substance manufacturer (who produces tafluprost)

For Zioptan, these tiers map to Alcon’s established ophthalmic manufacturing ecosystem in collaboration with specialized sterile and ocular CMOs that support preservative-free formats.

What entities are typically listed on sourcing and regulatory filings for Zioptan?

Zioptan’s supplier identifiers in regulatory and distribution workflows typically align with:

• Marketing authorization holder / NDA sponsor
• Manufacturer of record for drug product
• Manufacturer of record for drug substance
• Secondary packager and distributor

What contract manufacturing sources make Zioptan?

Zioptan’s sterile ocular product manufacture requires:

• Sterile filtration and aseptic processing controls
• Controlled particulate/bioburden release testing
• Ocular compatibility and container closure integrity testing
• Stability and extractables compatibility work for ophthalmic dosing units

In practice, sterile ophthalmic CMOs used for products like Zioptan are selected based on:

• Aseptic capability and cleanroom classification
• Ocular-specific validation experience
• Ability to support single-use, preservative-free dosing formats
• Ability to run low-volume/high-complexity ophthalmic lots at scale

For Zioptan, the contract manufacturing and fill-finish capability is embedded in the global Alcon ophthalmic supply chain used for preservative-free ocular solutions and related sterile ophthalmics.

Which companies supply the drug substance (tafluprost API) for Zioptan?

Tafluprost API supply is typically handled by specialized API sites with:

• Validated synthetic routes for prostaglandin analogs
• Impurity profile control meeting ophthalmic regulatory expectations
• GMP supply chains supporting global markets

Zioptan API supply is sourced from the upstream manufacturers supporting the brand’s global drug substance program through the same industrial network that supports sterile ocular fill-finish.

How can buyers verify the Zioptan supplier of record?

High-integrity verification for continuity, procurement risk, or litigation discovery usually relies on:

• FDA drug establishment listings for the drug product and drug substance sites
• Orange Book and labeling “Manufactured for / Distributed by / Manufactured by” statements
• DMF or ASMF-linked manufacturer identification when available for the active substance
• Lot-specific certificates of analysis (CoA) issued by the manufacturer of record and distributor

For Zioptan, the operational route is:

1. Pull the supplier of record from the US product labeling on the specific marketed presentation
2. Cross-check with FDA establishment registrations for that site
3. Confirm packaging manufacturer and distributor from the label and lot documentation

What patent or regulatory events change supplier availability for Zioptan?

Supplier availability can change due to:

• Manufacturing site transfers
• Sterile line revalidations
• Supply interruptions tied to GMP remediation or inspection findings
• Post-approval change filings for container closure, fill volume, or process parameters

For Zioptan specifically, supply continuity depends on maintaining sterile manufacturing performance for preservative-free ocular solutions and meeting stability requirements for packaging.

What generic or biosimilar entry risks exist that could alter Zioptan sourcing?

Zioptan is a small-molecule ophthalmic product (not a biologic). “Biosimilar” risks do not apply. Generic entry risks depend on:

• Patent estate expiry and exclusivity periods
• Paragraph IV or other challenges (if any) and resultant settlement timelines
• Regulatory approval of ANDA products using the same or different manufacturing processes

When generic products launch, sourcing shifts from brand-only supply to a multi-source market where:

• API supply may remain centralized or diversify
• Sterile fill-finish capacity becomes a key bottleneck

Key takeaways on Zioptan suppliers

• Zioptan supply in major markets is executed through a coordinated ophthalmics manufacturing ecosystem aligned with the brand’s established global supply chain for preservative-free sterile ocular dosing.
• Supplier verification for procurement and risk management should be done via labeling “manufactured/distributed by” statements, FDA establishment listings, and lot CoAs.
• Any supplier diversification depends on ANDA approvals and validated sterile fill-finish capacity.

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FAQs

1) Who is the US marketer/distributor for Zioptan?
Zioptan is marketed in the US by Santen Inc.

2) Is Zioptan preservative-free?
Yes, Zioptan is formulated as a preservative-free ophthalmic solution intended for ocular dosing.

3) What type of manufacturing is required for Zioptan?
Zioptan requires sterile ophthalmic manufacturing including aseptic processing and ocular quality controls.

4) Can suppliers change without FDA visibility?
Manufacturing site and process changes typically require regulatory filings; the manufacturer of record is reflected through labeling and FDA establishment data.

5) Are there biosimilars to Zioptan?
No, Zioptan is a small-molecule ophthalmic drug, so biosimilar pathways do not apply.

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References (APA)

1. FDA. (n.d.). Drug establishment search. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
3. FDA. (n.d.). Approved Drug Products and Associated Patents (Orange Book) data files. U.S. Food and Drug Administration. https://www.fda.gov/drugs/
4. Santen Inc. (n.d.). Zioptan (tafluprost ophthalmic solution) US prescribing information/labeling.